COPENHAGEN, Denmark—Continuing a relationship that began in 2011 with a development program focused on novel dual-acting glucagon/GLP-1 receptor agonists to treat type 2 diabetes and/or obesity, Zealand Pharma A/S recently signed a second global exclusive license, research and development collaboration with Ingelheim, Germany-based Boehringer Ingelheim (BI) around a novel therapeutic peptide project from Zealand’s portfolio of preclinical programs. The aim of this new deal is to develop novel medicines for improved treatment of patients with cardio-metabolic diseases against an as-yet-undisclosed target.
Although the first deal has changed over the years, with the initial compound having been discarded and replaced with a new one, the parties note that this new collaboration “reflects the confidence both parties have in each other and of their complementary expertise in the research and development of new medicines.”
“This second agreement secures additional funding and attractive value potential to Zealand. It demonstrates our strong partner relations with Boehringer Ingelheim, leveraging Zealand’s expertise in the design and development of therapeutic peptides to now cover an additional target in the cardio-metabolic disease area,” said David H. Solomon, president and CEO of Zealand. “We look forward to working with Boehringer Ingelheim towards selection of the first preclinical peptide therapeutic to be advanced in development under this new agreement.”
In 2014, BI will make payments of €5.6 million to Zealand, or about $7.24 million, with Zealand eligible to receive up to €295 million ($381.5 million) in potential milestone payments for the first commercialized product plus research funding and royalties. BI will obtain global exclusive development and commercial rights to products under the agreement, with Zealand retaining co-commercialization rights in Scandinavia.
“Partnering is key to our business strategy, and the relationship with Zealand is a long-term and important one,” according to Dr. Michel Pairet, BI’s senior vice president of research and development for non-clinical. “We are, therefore, extremely pleased to enter into this new agreement with Zealand, a company recognized as experts in their field, which will further complement and strengthen our own discovery and development efforts in the area of cardio-metabolic diseases.”
This new agreement calls for Zealand and BI to combine their research expertise for up to four-and-a-half years, focusing on the continued discovery, identification and characterization of novel peptide medicine candidates within the selected therapeutic target area of cardio-metabolic disease. The companies will work together to advance the therapeutic peptides stemming from this research collaboration into preclinical development. Boehringer Ingelheim will be responsible for the conduct of preclinical and clinical development, as well as for the commercialization, and will solely fund the research, development and commercialization of products under the agreement.
The new agreement with BI is expected to positively affect Zealand’s revenue and other operating income. The company has, therefore, raised its full-year revenue guidance to €18 million from €13 million and lowered its expectations on net operating expenses in 2014 to between €25 million and €28 million from €26 million to €29 million.
Zealand Pharma is a biotechnology company with expertise in the discovery, design and development of novel peptide medicines and a mature portfolio of therapeutic products, which are all based on internal inventions. The company’s focus lies in the field of cardio-metabolic diseases, diabetes and obesity in particular, and its lead product is lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of type 2 diabetes, marketed as Lyxumia under a license agreement with Sanofi. Lyxumia is approved in several countries globally, including Europe and Japan. In the United States, submission of a New Drug Application is expected in 2015, after completion of a cardiovascular outcome study called ELIXA. A once-daily single injection combination of Lyxumia and Lantus (LixiLan) is in Phase 3 development by Sanofi with planned first regulatory filing as early as the end of 2015.
Zealand has a partnering strategy for the development and commercialization of its products, and in addition to the license agreement with Sanofi in type 2 diabetes, the company has two collaborations with BI in diabetes/obesity and cardio-metabolic diseases, one with Eli Lilly and Co. in diabetes and obesity, one with Helsinn Healthcare in chemotherapy-induced diarrhea and a license agreement with AbbVie in acute kidney injury.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies and operates globally with 142 affiliates and more than 47,000 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2013, Boehringer Ingelheim achieved net sales of about €14.1 billion, with research and development expenditures corresponding to 19.5 percent of its net sales.
As noted earlier, in June 2011 Zealand signed a license, research and development collaboration agreement with BI to advance novel glucagon/GLP-1 dual-acting (GGDA) peptide receptor agonists for the treatment of patients with type 2 diabetes and/or obesity. The research part of the collaboration was successfully completed in June 2013 with a portfolio of novel GGDA compounds handed over to BI. However, in January of this year, it was decided to adapt the development program, discontinue work with the compound ZP2929 and select a new lead candidate from the portfolio of novel compounds invented under the research part of the agreement, with the financial terms of the deal remaining unchanged.
Zealand plans to continue the development of ZP2929. Solomon said at the time, “Our collaboration with Boehringer Ingelheim has been fruitful, and we both continue to share excitement and strong commitment as to the potential of dual-acting glucagon/GLP-1 agonists as a unique and promising new approach to delivering better healthcare solutions to patients with diabetes and/or obesity. However, on ZP2929 we have differed in our views regarding the appropriate way forward in the development of this drug candidate. As a consequence, we have agreed with Boehringer Ingelheim that Zealand will retain the full control over the program, leaving us the opportunity to apply our unique peptide drug capabilities to its continuation. In parallel, under the collaboration, we will continue to work closely with Boehringer Ingelheim in the selection of a new lead candidate as well as on the development plan for this compound going forward.”